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FDA 510(k)

ACE-DUPONT COMPOSITE RINGS

K-Number: K955388 · 1996-01-31

ApplicantAce Medical Co.
Decision Date1996-01-31
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE-DUPONT COMPOSITE RINGS is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical Co.. It received FDA 510(k) clearance on 1996-01-31 under 510(k) number K955388. The device is classified under product code LXT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE-DUPONT COMPOSITE RINGS?

ACE-DUPONT COMPOSITE RINGS is a medical device that received FDA 510(k) clearance on 1996-01-31. The listed applicant is Ace Medical Co.. The 510(k) number is K955388.

When did ACE-DUPONT COMPOSITE RINGS receive FDA 510(k) clearance?

ACE-DUPONT COMPOSITE RINGS received FDA 510(k) clearance on 1996-01-31, under 510(k) number K955388.

Who is the listed applicant for ACE-DUPONT COMPOSITE RINGS?

The FDA 510(k) record lists Ace Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACE-DUPONT COMPOSITE RINGS?

The FDA product code for ACE-DUPONT COMPOSITE RINGS is LXT.

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Other records listing Ace Medical Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972183DEPUY ACE A.I.M. TITANIUM TIBIAL NAILK955472ACE HUMERUS & RADIUS PLATESK9544856.5MM SOLID CANCELLOUS BONE SCREWK954069ACE CERVICAL TRACTION HALOZS, TONGS & PINSK950618ACE SUPRACONDYLAR PLATEK933968ACE PELVIC STABILIZER

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Related Devices (Code: LXT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230067Para-Fix External Fixation SystemNew Paradigm BiomedicalK131636POLARUS CONNECTAcumed, LLCK132704DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWBiometK112345DISTAL VOLAR RADIUS PLATING SYSTEMSMedos International SARLK090374STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(SDePuy Orthopaedics, Inc.K073135SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONSSynthes (Usa)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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